| NDC Code | 58602-703-76 |
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| Package Description | 4 BLISTER PACK in 1 CARTON (58602-703-76) / 6 TABLET, FILM COATED, EXTENDED RELEASE in 1 BLISTER PACK |
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| Product NDC | 58602-703 |
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| Product Type Name | HUMAN OTC DRUG |
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| Proprietary Name | Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride |
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| Non-Proprietary Name | Cetirizine Hydrochloride And Pseudoephedrine Hydrochloride |
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| Dosage Form | TABLET, FILM COATED, EXTENDED RELEASE |
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| Usage | ORAL |
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| Start Marketing Date | 20230308 |
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| Marketing Category Name | ANDA |
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| Application Number | ANDA212409 |
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| Manufacturer | Aurohealth LLC |
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| Substance Name | CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE |
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| Strength | 5; 120 |
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| Strength Unit | mg/1; mg/1 |
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| Pharmacy Classes | Adrenergic alpha-Agonists [MoA], Histamine H1 Receptor Antagonists [MoA], Histamine-1 Receptor Antagonist [EPC], alpha-Adrenergic Agonist [EPC] |
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